Diagnostic Performance of Urinary Gluten Immunogenic Peptides in Monitoring the Adherence to Gluten-free Diet.

Study Purpose

The purpose of the GRRES study is to assess the clinical usefulness of urinary gluten immunogenic peptides test as a marker of gluten-free diet adherence using the rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 20 Years - 40 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - healthy volunteers - 20-40 years old - written informed consent

    Exclusion Criteria:

    - type 1 diabetes - chronic or acute inflammatory diseases of the gastrointestinal tract (CD, non-celiac gluten sensitivity, Crohn's disease, ulcerative colitis, food allergy, acute gastroenteritis ≤ 4 weeks prior to the study start) - pregnancy or lactation - chronic intake of medications and supplements - refusal/withdrawal of written informed consent.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04477239
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Università Politecnica delle Marche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Carlo Catassi, MD, MPHElena Lionetti, MD, PHDSimona Gatti, MD, PHDChiara Monachesi, PHDAnil K Verma, PHD
Principal Investigator Affiliation Univeristà Politecnica delle Marche, Ancona, ItalyUniveristà Politecnica delle Marche, Ancona, ItalyUniveristà Politecnica delle Marche, Ancona, ItalyUniveristà Politecnica delle Marche, Ancona, ItalyUniveristà Politecnica delle Marche, Ancona, Italy
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Additional Details

A strict and permanent gluten free diet (GFD) is the only effective treatment resulting in full clinical, serological and histological remission, avoiding long-term complications in celiac disease (CD) patients. Gluten immunogenic peptides (GIP) are fragments of gluten proteins resistant to gastrointestinal digestion and detectable in urine after intestinal digestion, providing direct evidence of recent gluten ingestion. A significant variability in the amount of excreted urinary GIP has been reported in individuals administered with similar doses of gluten and, so far, inadequate information is available about the amount of excreted GIP in subjects ingesting traces or low amount of gluten. This is an important issue, as even a strict GFD could be contaminated by traces of gluten, e.g. in wheat starch and processed food. The aim of this study is to assess the clinical usefulness of urinary GIP as a marker of GFD adherence using a rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies. This is a prospective, randomized, triple-blind, placebo-controlled, crossover clinical trial. In this study, healthy volunteers following a normal diet will be requested to be on strict GFD for 5 days. On day 4th, participants will be requested to collect a baseline urine sample and in case of a negative GIP test result they will be assigned to ingest a specific dose of purified gluten incorporated in a capsule (0 mg, 10 mg, 50 mg, 100 mg, 500 mg and 1000 mg, according to randomization). Participants will be requested to collect urine samples in a container and take a 5 mL aliquote for the GIP test at the 9th and 24th hour from the time of the administration of the dose. During the collection, volunteers will also be requested to record the volume of the excreted urine and to store the collected urine at 4°C. Urine tubes will be stored at -20°C until the quantitative evaluation of GIP. GIP test will be performed using the rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies iVYCHECK GIP Urine™ test (Biomedal, Spain) according to the manufacturer's instructions.

Arms & Interventions

Arms

Placebo Comparator: Placebo

Oral administration of one capsule of Placebo

Active Comparator: Purified gluten (10 mg)

Oral administration of capsules containing 10 mg of purified gluten.

Active Comparator: Purified gluten (50 mg)

Oral administration of capsules containing 50 mg of purified gluten.

Active Comparator: Purified gluten (100 mg)

Oral administration of capsules containing 100 mg of purified gluten.

Active Comparator: Purified gluten (500 mg)

Oral administration of capsules containing 500 mg of purified gluten.

Active Comparator: Purified gluten (1000 mg)

Oral administration of capsules containing 1000 mg of purified gluten.

Interventions

Behavioral: - Gluten (behaviour)

Gluten is a protein normally present in the daily diet of healthy volunteers not suffering from gluten related disorders, in far greater quantities (10-20 g/day) than those used in this study (10 mg-1 g/day).

Behavioral: - Placebo (behaviour)

Placebo is composed of pregelatinized maize starch Ph.Eur. 97.5%; magnesium stearate Ph.Eur. 1.5%; micronized silica Ph.Eur. 0.5%; Micronized talc Ph.Eur. 0.5% (NOT containing preservatives, colorings, or gluten).

Contact a Trial Team

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International Sites

University Department of Pediatrics, Ancona, Italy

Status

Recruiting

Address

University Department of Pediatrics

Ancona, , 60123

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